Jobs at Aspen Pharma Group

Description
Overview:

• Drive the implementation of production activities and take accountability for the meeting of production targets
• Ensure OTIF delivery within cost budgets
• Lead and drive outputs of the following units: Production, QC, HC, Production Planning and Maintenance

Responsibilities:

Production Management

• Manage, organise, control and supervise all aspects of the site in line with company policies and procedures
• Ensure the timely supply of quality products to customers
• Ensure that proper maintenance is carried out on equipment, utilities and manufacturing areas

Risk Management and Compliance

• Ensure that production documentation is GMP and legislation- compliant, on-time and reviewed prior to approval
• Implement/ support risk-based approaches for manufacturing operations and equipment

Quality and Continuous Improvement

• Oversee the development and implementation of, and adherence to, SOPs in the department and ensure GMP compliance
• Ensure the areas of the department meet hygiene and cleanliness standards and that equipment/ process validations are performed
• Ensure that products are produced and stored according to appropriate documentation to obtain required quality
• Support QA/ QC in quality investigations and represent the department during inspections and audits, as and when required
• Explore competitor activity, market trends and new initiatives
• Motivate, train and develop dept. heads and their direct reports
• Agree business plans and performance targets with department managers and monitor these, taking necessary corrective actions

Organisational Support and Functional Management

• Manage, organise, control and supervise the process of approved capital expenditure, ensuring financial, conceptual and phasing objectives are achieved in line with company policy
• Participate in the development and lead the implementation of the strategic vision and direction for business-critical functions across SA, as well as all related plans, policies and procedures
• Perform financial and human resources functions to ensure optimal management of function and reporting units and leaders
• Manage collaboration and coordination between reporting units
• Maintain/ support positive customer engagements and problem resolution

Manage the site within agreed budgets

Requirements
Background/experience

• 10 years’ related experience with strong manufacturing experience
• Managing a strategic production site (ideally in a pharmaceutical environment)
• Management of projects in an international context
• Proven leadership capability and managerial experience at a senior level
• Minimum of Bachelor’s degree, ideally in Engineering

Specific job skills

• In-depth insight into pharmaceutical manufacturing and pharmaceutical standards/ compliance
• Deep understanding of quality, operations and logistics
• People and departmental management

Competencies

• Translating Strategy
• Interpreting and Internalising Information
• Offering Insights
• Making Decisions
• Managing Performance
• Customer Awareness

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Description
Overview

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures and document controls
• Deliver expected productivity targets as per business requirements
• Related administrative tasks
• Serve as back up to Team Leader on shift

Responsibilities

Planning and Procedures

• Plan and prioritise daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally

Inspections and Verifications

• Verify schedule 5 products
• Verify certified clean status of rooms and equipment
• Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials

Line and Production Processing

• Perform, review and approve line sign-on’s, closures and clearance authorisations
• Perform, review and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications

Process and System Improvements

• Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus

Compliance and Auditing

• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Review and approve preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions, and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required 

Training and Technical Expertise

• Train new Pharmacists and PMAs on SOPs in transition period
• Identify refresher or awareness training needs

Administration and Record Keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Requirements
Background/experience

• BPharm Degree
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information gathering
• Interrogating information
• Meeting deadlines
• Finalising output
• Taking action

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Description
Overview

• Conduct in-process compliance to quality procedures, standards and specifications for value stream operations
• Review and approve Annual Performance Quality Review (APQR) and quality related activities
• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs
• Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines.
• Control of documentation in compliance with regulation and company policies and procedures
• Ensure all relevant GMP and GDP processes are described in the current SOPs and re adhered to correctly.
• Perform quality risk assessments, establish risk controls and review risks to assist with the quality risk management process.

Responsibilities

Planning and Procedures

• Provide technical and operational input during drafting of plans and procedures specific to unit
• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors 

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards and product specifications
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
• Approve and release production batches
• Execute batch release priorities in line with OTIF and planning schedule
• Ensure release requirements are met for finished products
• Determine disposition of in-process and finished products for clinical and commercial use
• Ensure changes/ deviations in production or quality control have been approved according to QMS
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations
• Ensure production and QC documentation are completed in compliance with SOPs
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
• Report observed deficiencies in process and follow up on corrective action
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production 

Process Compliance

• Identify systematic technical and process issues by reviewing CAPA requests and trends
• Systematic investigation of the root causes of identified problems and risks for corrective action or prevention
• Develop CAPA plans and change incidents to address process compliance
• Implement operational changes to SOPs and processes, in compliance with control processes
• Ensure deviations (planned/ unplanned) are documented, reviewed, and analysed and recommend validation activities to be performed
• Execute change control process by ensuring changes are documented, reviewed and approved

Annual Performance and Quality Review

• Review APQRs to assess production risks and quality of in-process control programs
• Review and analyse CAPA plans to assess impact on quality procedures and standards

Retention Sample Management

• Store and manage retention samples as per guidelines.

In Process Quality Management

• Review and approve outcome if in-process internal inspections.

Reporting

• Ensure the filing, retrieving, and archiving of documents on the soft and hard copy filing systems.
• Maintain and update records and systems as required.
• Provide information for reports on weekly/monthly basis, as required by superiors.
• Compile and complete standardised reports and consolidate standardised documents.

Requirements
Skills Required

Background/experience

• BPharm Degree with 2 years’ pharmaceutical manufacturing experience
• South African Pharmacy Council registration
• 1-year related work experience

Competencies

• Information gathering
• Interrogating information
• Finalizing Input
• Offering Insights
• Meeting deadlines
• Taking action